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| Name | Class |
|---|---|
| Hunan Xeno-life Science Ltd | UNKNOWN |
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The neonatal pig islets will be used as donor culturing with our modified culture medium. At the same time the autologous T regulatory cells will be used to induce specific immune tolerance for porcine islets grafts combined the costimulation of T cell activation channel blockers. The treatment for type 1 diabetes will be evaluated the efficacy and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Porcine islets and autologous treg | Experimental | Porcine islets:10000 islet equivalent(IEQ)/Kg; Treg:2x10^6/Kg |
|
| AutologousTreg | Active Comparator | Autologous Treg:2x10^6/Kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Porcine islets | Other | Porcine islets: 10000IEQ/Kg; Tacrolimus: 0.087mg/kg, Bid; mycophemo-latemofetil (MMF): 1g x 2/d; NULOJIX(belatacept): Day 1 (prior to transplantation), Day 5, Week 2, Week 4, Week 8, Week 12 10mg/kg |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose | Before and after transplantation the patient will be tested the blood glucose. If the blood glucose within 24 hours is stable and no occurrence of diabetic ketoacidosis and hypoglycemia.Thirty percent reduction of exogenous insulin requirement will be considered as effective. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Porcine C-peptide | The patient will be detected the porcine C-peptide levels after transplantion every three months. | 1 years |
| Hemoglobin A1c | After transplantation the patient will be checked hemoglobin A1c every month.The level of HbA1c less than 6.5% was considered as effective. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Wang, PHD,MD | Cell transplantation and gene therapy, the 3rd Xiangya hospital of Central South University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cell Transplantation and Gene Therapy Institute | Changsha | Hunan | 410013 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42305014 | Derived | Ma X, Mo Z, Chen Y, Zhang S, Liang Q, Zhang J, Dong Q, Yang C, Yang M, Luo MH, Rong P, Cui J, Wang W. Clinical Trial for Safety of Porcine Islet Xenotransplantation From PERV-C Free DPF Donor Piglets in Patients With Type 1 Diabetes. Xenotransplantation. 2026 May-Jun;33(3):e70148. doi: 10.1111/xen.70148. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Autologous Treg | Other | Autologous Treg: 2x10^6/Kg |
|
| 1 years |
| AST | AST will be tested every three months. | 1 years |
| ALT | ALT will be tested every three months. | 1 years |
| Scr | Scr will be tested every three months. | 1 years |
| BUN | BUN will be tested every three months. | 1 years |
| Ultrasonic examination for liver | Ultrasonic examination will be used for the recipient's liver before transplantation and every three month post transplantation. | 1 years |
| MRI for liver | MRI will be used for liver before transplantaion and every three month post transplantation. | 1 years |
| Virus detection | The recipient's serum and peripheral blood monouclear cells (PBMC) will be collected for virus detection every six months. | 2 years |
| Immune cells detection | The recipient's peripheral blood monouclear cells (PBMC) and the serum will be collected for immune cell's analysis. | 1 years |
| Cytokine detection | The recipient's peripheral blood monouclear cells (PBMC) and the serum will be collected cytokine beads array (CBA) test. | 1 years |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |